欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/2489/001
药品名称
Respilukas
活性成分
Montelukast sodium salt 10.0 mg
剂型
Film-coated tablet
上市许可持有人
Teva Denmark A/S Parallelvej 10 2800 Lyngby Denmark
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Denmark (DK)
Respilukas
Spain (ES)
许可日期
2012/05/24
最近更新日期
2025/01/09
药物ATC编码
R03D OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R03DC03 montelukast
R03DC Leukotriene receptor antagonists
申请类型
TypeLevel1:
[not specified]
TypeLevel2:
[not specified]
TypeLevel3:
[not specified]
TypeLevel4:
[not specified]
TypeLevel5:
[not specified]
附件文件下载
Final Labelling
|
1_3_1 label_outer_10mg_eu clean
Date of last change:2024/09/06
PubAR
|
Final PAR Scientific discussion Respilukas DKH2092_001_DC
Date of last change:2024/09/06
Final PL
|
Montelukast_DK_H_2092_001_PIL_20_05_19
Date of last change:2024/09/06
Final SPC
|
Montelukast_DK_H_2092_001_SmPC_20_05_19
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase